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Evaluate the Effects of An AI System on Colonoscopy Quality of Novice Endoscopists

Primary Purpose

Colonoscopy, Artificial Intelligence, Gastrointestinal Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
artificial intelligence assistance system
Sponsored by
Renmin Hospital of Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female ≥18 years old;
  2. Able to read, understand and sign an informed consent;
  3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
  4. Patients requiring colonoscopy.

Exclusion Criteria:

  1. Have drug or alcohol abuse or mental disorder in the last 5 years;
  2. Pregnant or lactating women;
  3. Patients with known multiple polyp syndrome;
  4. patients with known inflammatory bowel disease;
  5. known intestinal stenosis or space-occupying tumor;
  6. known colon obstruction or perforation;
  7. patients with a history of colorectal surgery;
  8. Patients with a previous history of allergy to pre-used spasmolysis;
  9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
  10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Sites / Locations

  • Renmin Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

novices with AI-assisted system

experts without AI-assisted system

novice without AI-assisted system

Arm Description

The novice doctors are assisted in colonoscopy with an artificial intelligence system that can indicate abnormal lesions and the speed of withdrawal in real-time, as well as feedback on the percentage of overspeed.

The expert doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips

The novice doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips

Outcomes

Primary Outcome Measures

Missed diagnosis rate of adenoma
The number of newly detected adenoma in the second examination divided by the total number of adenoma detected in both examinations

Secondary Outcome Measures

Detection rate of advanced adenoma
The numerator is the number of patients diagnosed with advanced adenomas, and the denominator is the total number of patients undergoing colonoscopy. Advanced adenoma was defined as > 10mm, villous adenoma, tubular villous adenoma, high-grade intraepithelial neoplasia, and carcinoma.
Polyp Detection Rate
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Average number of adenomas detected per patient
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The detection rate of large, small and micro polyps
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of large, small and micro polyps detected
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
The detection rate of large, small and micro adenomas
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of large, small and micro adenomas detected
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The detection rate of adenoma in different sites
The numerator is the number of patients with adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of adenomas detected in different sites
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Detection rate of adenoma
The numerator is the number of patients diagnosed with adenomas, and the denominator is the total number of patients undergoing colonoscopy.

Full Information

First Posted
March 1, 2022
Last Updated
March 22, 2023
Sponsor
Renmin Hospital of Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT05323279
Brief Title
Evaluate the Effects of An AI System on Colonoscopy Quality of Novice Endoscopists
Official Title
Evaluate the Effects of An Artificial Intelligence System on Colonoscopy Quality of Novice Endoscopists: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this study, the AI-assisted system EndoAngel has the functions of reminding the ileocecal junction, withdrawal time, withdrawal speed, sliding lens, polyps in the field of vision, etc. These functions can assist novice endoscopists in performing colonoscopy and improve the quality.
Detailed Description
Colonoscopy is a crucial technique for detecting and diagnosing lower digestive tract lesions. The demand for endoscopy is high in China, and endoscopy is in short supply. However, a colonoscopy is a complex technical procedure that requires training and experience for maximal accuracy and safety. The ability of different endoscopists varies greatly. Novice endoscopists generally have difficulty and high risk in entering colonoscopy, requiring experts' assistance. To some extent, this wastes the novice's productivity. If investigators can arrange the working mode of experts entering and novices withdrawing endoscopy, the clinical efficiency and resource utilization rate can be significantly improved. However, investigators must consider the poor examination ability of novice endoscopists. It is reported that the detection rate of adenoma in colonoscopy performed by endoscopists with different seniority is 7.4% ~ 52.5%. If the examination ability of novice endoscopists can be improved, this concern can be eliminated. Deep learning algorithms have been continuously developed and increasingly mature in recent years. They have been gradually applied to the medical field. Computer vision is a science that studies how to make machines to "see". Through deep learning, camera and computer can replace human eyes to carry out machine vision such as target recognition, tracking and measurement. Interdisciplinary cooperation in medical imaging and computer vision is also one of the research hotspots in recent years. At present, it is mainly applied to the automatic identification and detection of lesions and quality control and has achieved good results. Investigator's preliminary experiments have shown that deep learning has high accuracy in endoscopic quality monitoring, which can effectively regulate doctors' operations, reduce blind spots and improve the quality of endoscopic examination. At the same time, it can also monitor the doctor's withdrawal time in real-time and improve the detection rate of adenoma. In the previous work of investigator's research group, investigators have successfully developed deep learning-based colonoscopy withdraw speed monitoring and intestinal cleanliness assessment and verified the effectiveness of the AI-assisted system EndoAngel in improving the quality of gastroscopy and colonoscopy in clinical trials. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy ability of novices. By comparing the performance of novices and novices with EndoAngel assistance and experts in colonoscopy, investigators want to explore whether artificial intelligence can assist novices to reach the expert level in colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Artificial Intelligence, Gastrointestinal Disease, Deep Learning

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
685 (Actual)

8. Arms, Groups, and Interventions

Arm Title
novices with AI-assisted system
Arm Type
Experimental
Arm Description
The novice doctors are assisted in colonoscopy with an artificial intelligence system that can indicate abnormal lesions and the speed of withdrawal in real-time, as well as feedback on the percentage of overspeed.
Arm Title
experts without AI-assisted system
Arm Type
No Intervention
Arm Description
The expert doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips
Arm Title
novice without AI-assisted system
Arm Type
No Intervention
Arm Description
The novice doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips
Intervention Type
Device
Intervention Name(s)
artificial intelligence assistance system
Intervention Description
The artificial intelligence assistance system can indicate abnormal lesions and real-time withdrawal speed and feedback the overspeed percentage.
Primary Outcome Measure Information:
Title
Missed diagnosis rate of adenoma
Description
The number of newly detected adenoma in the second examination divided by the total number of adenoma detected in both examinations
Time Frame
A month
Secondary Outcome Measure Information:
Title
Detection rate of advanced adenoma
Description
The numerator is the number of patients diagnosed with advanced adenomas, and the denominator is the total number of patients undergoing colonoscopy. Advanced adenoma was defined as > 10mm, villous adenoma, tubular villous adenoma, high-grade intraepithelial neoplasia, and carcinoma.
Time Frame
A month
Title
Polyp Detection Rate
Description
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Time Frame
A month
Title
Average number of adenomas detected per patient
Description
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of large, small and micro polyps
Description
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of large, small and micro polyps detected
Description
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of large, small and micro adenomas
Description
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of large, small and micro adenomas detected
Description
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of adenoma in different sites
Description
The numerator is the number of patients with adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of adenomas detected in different sites
Description
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
Detection rate of adenoma
Description
The numerator is the number of patients diagnosed with adenomas, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 years old; Able to read, understand and sign an informed consent; The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures; Patients requiring colonoscopy. Exclusion Criteria: Have drug or alcohol abuse or mental disorder in the last 5 years; Pregnant or lactating women; Patients with known multiple polyp syndrome; patients with known inflammatory bowel disease; known intestinal stenosis or space-occupying tumor; known colon obstruction or perforation; patients with a history of colorectal surgery; Patients with a previous history of allergy to pre-used spasmolysis; Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants; High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Honggang, Doctor
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China

12. IPD Sharing Statement

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Evaluate the Effects of An AI System on Colonoscopy Quality of Novice Endoscopists

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